A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants.
This is a single center, double-blind, randomized, placebo-controlled, first-in-human (FIH) study of BMF-650, an oral non-peptide GLP-1 receptor agonist administered to otherwise healthy overweight or obese participants. Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Interventional Product
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Assess safety and tolerability of BMF-650
Incidence of adverse events (AEs)
Time frame: 6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650
Vital signs like blood pressure
Time frame: 6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650
ECG measures like QTcF interval
Time frame: 6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650
Physical examinations like general appearance
Time frame: 6 weeks (Part 1) and 11 weeks (Part 2)
Assess safety and tolerability of BMF-650
Safety labs like clinical chemistry
Time frame: 6 weeks (Part 1) and 11 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Tmax
Time frame: 2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states
Cmax
Time frame: 2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states
AUC(0-last)
Time frame: 2 weeks (Part 1) and 6 weeks (Part 2)
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Evaluate PK and food effect of BMF-650 in fed and fasted states
AUC(0-inf)
Time frame: 2 weeks (Part 1) and 6 weeks (Part 2)
Evaluate PK and food effect of BMF-650 in fed and fasted states
T1/2
Time frame: 2 weeks (Part 1) and 6 weeks (Part 2)
Assess the impact of multiple ascending doses of BMF-650 on weight (Part 2 only)
Percent change in body weight compared to baseline
Time frame: 6 weeks